Light Therapy Device for Neonatal Intraventricular Hemorrhage Grade 3 and 4

Part of paid clinical trials in Newark, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT06797219
Status
Recruiting
Apply to this trial

Conditions

  • Hydrocephalus
  • Intraventricular Hemorrhage of Prematurity

Eligibility Criteria

Sex
ALL
Age
0 Days - 1 Month
Healthy Volunteers
Not accepted

Interventions

  • Low Level Laser Therapy for Intraventricular Hemorrhage of Prematurity — DEVICE
    The experimental arm will be administered treated with the study device. It will be 10 mW/cm\^2 of 650nm laser through use of a novel laser device given for 5 minutes twice daily for 12 days.

Study Details

The primary purpose of this study is to serve as a pilot study of the EFIL device treatment feasibility of IVH grades 3,4 to guide development of a larger trial. Primary outcomes will assess the following: safety of intervention, recruitment and consent process, acceptability of intervention by parents, retention rates, selection of most appropriate outcome measures, provide sample size estimates for a larger trial, increase the researchers\' experience with the study intervention. A complete list of objectives and aims are listed under "Objectives". This study hopes to treat 12-24 neonates using 650nm light of irradiance 10mW/cm2 for 5 minutes twice a day each day for 12 days. We will also call the parents at 6 months and 12 months to track developmental milestones.

Key Dates

Start date
Feb 25, 2025
Status verified
Jul 2025
Primary completion
Jul 1, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Non-blinded, open label experimental arm
    The experimental arm will be administered treated with the study device. It will be 10 mW/cm\^2 of 650nm laser through use of a novel laser device given for 5 minutes twice daily for 12 days.

Primary Outcome Measure

Hemorrhage Resorption Rate [ Time Frame: Hemorrhage resorption rate tracking starts from date of identified intraventricular hemorrhage on head ultrasound (usually within 1 week of life) and head ultrasounds weekly up to 4 months old ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Newark Beth Israel Medical CenterNewarkNew Jersey07112
Garrett Gianneschi
[email protected]
9082941161
Onajovwe Fofah, MD (PRINCIPAL_INVESTIGATOR)
Rutgers - New Jersey Medical School / University HospitalNewarkNew Jersey07103
Garrett Gianneschi, DO
[email protected]
9082941161
Bellipady Rai, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Newark Beth Israel Medical Center· Newark, NJRutgers - New Jersey Medical School / University Hospital· Newark, NJ

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